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Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes (TRACK-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00786136
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : April 10, 2013
Sponsor:
Information provided by (Responsible Party):
Han Yaling, MD, Shenyang Northern Hospital

Study Description
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Brief Summary:

The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI.

The aim of this multicenter prospective, randomized, controlled study is to evaluate whether statins treatment during the perioperative period would reduce the risk of CIAKI in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography or noncoronary angiography, and evaluate the influence of such potential benefit on short-term outcome.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Chronic Kidney Disease Drug: rosuvastatin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2998 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient
Study Start Date : December 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
perioperative rosuvastatin administration for at least 5 dosages
 Drug: rosuvastatin
rosuvastatin
Placebo Comparator: control
blank control of perioperative statin administration
 Drug: rosuvastatin
rosuvastatin


Outcome Measures
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Primary Outcome Measures :
  1. An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure [ Time Frame: 72 h ]

Secondary Outcome Measures :
  1. The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes. [ Time Frame: 30 d ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned diagnostic coronary or peripheral artery angiography
  • T2DM
  • CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2
  • Statin naive, or not on statin treatment for at least 14 days
  • Withdrawal metformin or aminophylline for 48h before angiography
  • Total iodixanol volume

Exclusion Criteria:

  • Hypersensitivity to iodine-containing compounds and statins
  • Type 1 diabetes mellitus
  • Ketoacidosis
  • Lactic acidosis
  • CKD stages 1,4 or 5 (eGFR≥90ml/min per 1.73m2 or eGFR<30ml/min per 1.73m2)
  • STEMI
  • NYHA class IV or hemodynamic instability
  • Administration of any iodinated CM within 14 days before randomization
  • LDL-C<1.82mmol/L（70mg/dL）
  • Hepatic dysfunction (ALT 3 times greater than upper normal limit)
  • Thyreoid insufficiency
  • renal artery Stenosis(unilateral >70％ or bilateral stenosis>50％)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786136


Locations
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Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
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Principal Investigator: Yaling Han, MD Shenyang Northern Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Han Yaling, MD, vice president, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT00786136    
Other Study ID Numbers: SYNH-20081028
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: April 10, 2013
Last Verified: April 2013
Keywords provided by Han Yaling, MD, Shenyang Northern Hospital:
diabetes mellitus
chronic kidney disease
contrast induced acute kidney injury
angiography
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
 Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors